AnxietyNCT05535491
The Effection Pain and Anxiety of a Breathing Exercise Applied Following Laparoscopic Cholecystectomy
A study testing Educational and Research Hospital in people with Anxiety and Pain, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
One important part of individual nursing care is that that nurses teach and apply breathing exercises, which are vital and increase the patient's quality of life, in the light of their current knowledge and skills. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Educational and Research Hospital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 25 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hospitalized in the general surgery clinics,
- with histories of laparoscopic cholecystectomy,
- consenting to take part.
Who cannot join
- Have a psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Lüleburgaz Devlet Hastanesi
Kırklareli, Merkez, 39020
About this study
Official title: The Effection Pain and Anxiety of a Breathing Exercise Applied Following Laparoscopic Cholecystectomy: A Randomized Controlled Study
One important part of individual nursing care is that that nurses teach and apply breathing exercises, which are vital and increase the patient's quality of life, in the light of their current knowledge and skills. The purpose of this study was therefore to determine the effect of postoperative breathing exercises on pain and anxiety in patients hospitalized in the general surgery clinic and who had undergone laparoscopic cholecystectomy.
Read the detailed description
Introduction: Several methods are employed for overcoming pain and anxiety that are frequently experienced in the postoperative period. This study was planned to determine the effect of a breathing exercise on patient pain and anxiety after laparoscopic cholecystectomy.
Methods: The sample determined using power analysis in this randomized, controlled, semi-experimental research performed in two hospitals in the west of Turkey between January and November 2019 consisted of 74 individuals (37 experimental and 37 controls). An information form involving descriptive characteristics, a visual analogue scale (VAS), and the State-Trait Anxiety Inventory (STAI I/II) were used for data collection. Descriptive statistical methods and parametric tests were employed in the data analysis.
- Being tested
- Educational and Research Hospital
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational and Research HospitalOther
breathing exercise
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 | Experimental | BREATHING EXERCISE GROUP Receives: Other: Educational and Research Hospital |
| GROUP 2 | No intervention | CONTROL GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative anxiety scores would be lower in the experimental group than in the control group.
Postoperative anxiety scores
Measured: six months
Postoperative pain score would be lower in the experimental group than in the control group.
Postoperative pain score
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Jan 2018
- Primary completion1 Jan 2019
- Study completion25 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Aydin Sayilan, Kırklareli University
- Investigators
- Aylin AYDIN SAYILAN, PhD, Study chair, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535491
- Sponsor's protocol ID
- P0115R00
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koras K, Karabulut N. The Effect of Foot Massage on Postoperative Pain and Anxiety Levels in Laparoscopic Cholecystectomy Surgery: A Randomized Controlled Experimental Study. J Perianesth Nurs. 2019 Jun;34(3):551-558. doi: 10.1016/j.jopan.2018.07.006. Epub 2018 Nov 20.
PubMed 30470466Saritas S, Genc H, Okutan S, Inci R, Ozdemir A, Kizilkaya G. The Effect of Comedy Films on Postoperative Pain and Anxiety in Surgical Oncology Patients. Complement Med Res. 2019;26(4):231-239. doi: 10.1159/000497234. Epub 2019 Mar 27.
PubMed 30921794Sao CH, Chan-Tiopianco M, Chung KC, Chen YJ, Horng HC, Lee WL, Wang PH. Pain after laparoscopic surgery: Focus on shoulder-tip pain after gynecological laparoscopic surgery. J Chin Med Assoc. 2019 Nov;82(11):819-826. doi: 10.1097/JCMA.0000000000000190.
PubMed 31517775Santivanez-Acosta R, Tapia-Lopez ELN, Santero M. Music Therapy in Pain and Anxiety Management during Labor: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2020 Oct 10;56(10):526. doi: 10.3390/medicina56100526.
PubMed 33050409Ju W, Ren L, Chen J, Du Y. Efficacy of relaxation therapy as an effective nursing intervention for post-operative pain relief in patients undergoing abdominal surgery: A systematic review and meta-analysis. Exp Ther Med. 2019 Oct;18(4):2909-2916. doi: 10.3892/etm.2019.7915. Epub 2019 Aug 19.
PubMed 31555379
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effection Pain and Anxiety of a Breathing Exercise Applied Following Laparoscopic Cholecystectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05535491
- Acronym / sponsor ID
- P0115R00
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One important part of individual nursing care is that that nurses teach and apply breathing exercises, which are vital and increase the patient's quality of life, in the light of their current knowledge and skills. The purpose of this study was therefore to determine the effect of postoperative breathing exercises on pain and anxiety in patients hospitalized in the general surgery clinic and who had undergone laparoscopic cholecystectomy.
Detailed description
Introduction: Several methods are employed for overcoming pain and anxiety that are frequently experienced in the postoperative period. This study was planned to determine the effect of a breathing exercise on patient pain and anxiety after laparoscopic cholecystectomy.
Methods: The sample determined using power analysis in this randomized, controlled, semi-experimental research performed in two hospitals in the west of Turkey between January and November 2019 consisted of 74 individuals (37 experimental and 37 controls). An information form involving descriptive characteristics, a visual analogue scale (VAS), and the State-Trait Anxiety Inventory (STAI I/II) were used for data collection. Descriptive statistical methods and parametric tests were employed in the data analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | Experimental | Other: Educational and Research HospitalBREATHING EXERCISE GROUP |
| GROUP 2 | No intervention | –CONTROL GROUP |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized in the general surgery clinics,
- with histories of laparoscopic cholecystectomy,
- consenting to take part.
Key exclusion criteria (1 listed)
- Have a psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational and Research Hospitalbreathing exercise | Other | GROUP 1 |
Primary outcome
Postoperative anxiety scores would be lower in the experimental group than in the control group.
Time frame: six months
Postoperative anxiety scores
Postoperative pain score would be lower in the experimental group than in the control group.
Time frame: six months
Postoperative pain score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Background: PubMed 30470466Koras K, Karabulut N. The Effect of Foot Massage on Postoperative Pain and Anxiety Levels in Laparoscopic Cholecystectomy Surgery: A Randomized Controlled Experimental Study. J Perianesth Nurs. 2019 Jun;34(3):551-558. doi: 10.1016/j.jopan.2018.07.006. Epub 2018 Nov 20.
- Background: PubMed 30921794Saritas S, Genc H, Okutan S, Inci R, Ozdemir A, Kizilkaya G. The Effect of Comedy Films on Postoperative Pain and Anxiety in Surgical Oncology Patients. Complement Med Res. 2019;26(4):231-239. doi: 10.1159/000497234. Epub 2019 Mar 27.
- Background: PubMed 31517775Sao CH, Chan-Tiopianco M, Chung KC, Chen YJ, Horng HC, Lee WL, Wang PH. Pain after laparoscopic surgery: Focus on shoulder-tip pain after gynecological laparoscopic surgery. J Chin Med Assoc. 2019 Nov;82(11):819-826. doi: 10.1097/JCMA.0000000000000190.
- Background: PubMed 33050409Santivanez-Acosta R, Tapia-Lopez ELN, Santero M. Music Therapy in Pain and Anxiety Management during Labor: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2020 Oct 10;56(10):526. doi: 10.3390/medicina56100526.
- Background: PubMed 31555379Ju W, Ren L, Chen J, Du Y. Efficacy of relaxation therapy as an effective nursing intervention for post-operative pain relief in patients undergoing abdominal surgery: A systematic review and meta-analysis. Exp Ther Med. 2019 Oct;18(4):2909-2916. doi: 10.3892/etm.2019.7915. Epub 2019 Aug 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aylin AYDIN SAYILAN, PhD study chair
Kırklareli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational and Research Hospital in people with Anxiety and Pain, run by Kırklareli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative anxiety scores would be lower in the experimental group than in the control group. (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05535491, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.